Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific batches of custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where the sterility assurance level cannot be verified, posing a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK custom tubing sets for extracorporeal circulation. The recall involves batch numbers 3000043292, 3000047704, 3000050576, 3000052263, 3000060362, 3000065492, 3000066201, and 3000071202. The product was distributed nationwide.
The recall was initiated because the closed stopcock and non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, creating a potential risk of non-sterile components being used in medical procedures.
Healthcare facilities and users of these specific tubing sets should stop using the affected batches immediately. Users should contact Maquet Cardiovascular, LLC for further instructions on how to return or replace the recalled products.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK Material: 701049346
- Manufacturer
- Maquet Cardiovascular, LLC
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 183 recalled by Maquet Cardiovascular, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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